Allantoin

Evidence Level: L5

Predicted Indications: 8

Allantoin

Pharmacist Assessment Report

Allantoin: Topical keratolytic and wound-healing agent → severe nonproliferative diabetic retinopathy

One-Sentence Summary

Allantoin is a topical skin-care agent with keratolytic, soothing and wound-healing properties, marketed in India in gel, cream and dusting powder products. The TxGNN model predicts it may be relevant to severe nonproliferative diabetic retinopathy, but no clinical trials and no publications currently support this direction, so the prediction rests on the model score alone.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	Severe nonproliferative diabetic retinopathy
TxGNN Prediction Score	0.9956
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (11 of 11) – CDSCO approval status is not included in this data
Number of Listed Products	11 (valid: 11)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism of action data for allantoin is not available. Allantoin is known as a topical keratolytic, wound-healing and anti-irritant ingredient, and all of its Indian products are applied to the skin.

No plausible link between allantoin and retinal microvascular disease is documented in the data compiled for this report. Diabetic retinopathy is a vascular complication of diabetes affecting the retina, and topical dermatologic use does not suggest ocular or systemic exposure relevant to the retina. The score of 0.9956 is a model-based output only and is not backed by any trial or literature evidence, so the prediction should be viewed as a hypothesis, not a supported finding.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
218715	Trioclin Gel	Tube of 15 gm gel	Not recorded
174331	Paknet-C Gel	Tube of 15 gm gel	Not recorded
95593	Glintra Gel	Tube of 30 gm gel	Not recorded
84965	F Next Dusting Powder	Box of 75 gm dusting powder	Not recorded
34860	Candid Gold Dusting Powder	Bottle of 100 gm dusting powder	Not recorded

Eleven valid registrations are on record; the five main ones are listed above.

Review correction (2026-11-06): Originally stated: “Eleven valid single-ingredient registrations are on record; the five main ones are listed above.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Safety Considerations

Please refer to the package insert for safety information.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has a high model score but no supporting clinical trials or publications, and no mechanistic rationale links a topical skin agent to retinal disease. Evidence remains at the model-prediction level (L5).

To proceed, the following is needed:

Mechanism of action data for allantoin and any plausible biological link to retinal microvascular pathology
Preclinical or published studies directly examining allantoin in diabetic retinopathy
Assessment of whether any ocular or systemic route of delivery is feasible, since current products are topical
Package insert warnings and contraindications from Indian regulatory sources

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-11-06	Removed: “single-ingredient”	Corrected	Indian Medicine Dataset

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.